Topical corticosteroid uses

Pharmacokinetic studies in men with Topicort® (desoximetasone) Ointment % with tagged desoximetasone showed no detectable level (limit of sensitivity: μg/mL) in 1 subject and and μg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces . Seven days after application, no further radioactivity was detected in urine or feces. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.

In summary, the three bioequivalence approaches that are currently consistently accepted by regulatory authorities are bioequivalence studies with clinical endpoints, in-vivo pharmacodynamic studies (in particular VCA for topical corticosteroid products), and waivers for topical solutions. Also, most require pharmacokinetic studies if there are safety concerns relating to systemic exposure. However, it is refreshing to see that the regulatory authorities are giving credence to alternative science-based methods for demonstration of bioequivalence, rather than insistence on clinical endpoint studies.

Topical steroids are available as creams, lotions, gels and ointments; selection of an appropriate product can also provide good moisturization of the skin. The wide spectrum of potencies and bases allows these mediations to be used both effectively and safely while under the care of an experienced physician.

During flares, over-the-counter moisturizing preparations that include a topical corticosteroid (such as clobetasone butyrate and hydrocortisone) are helpful to control inflammation and restore the skin barrier. The intensive use of emollient-based products can reduce the need for topical steroids.

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Topical corticosteroid uses

topical corticosteroid uses

Cream, ointment, solution, gel, or lotion: Apply to affected area two to four times a day

Comments:
-Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions.
-If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-The safety and efficacy of drug use for longer than 4 weeks have not been established.

Use: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

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